Study on the function and the responsibilities of ethics committees in Japan

越来越多的伦理委员会(ECs)表明，在日本的临床环境中，决策过程发生了重大变化。这项研究的目的是：1)调查现状；2)制定在综合医院环境下建立和运行EC的指导方针；3)探讨EC的自由裁量权和责任程度；4)提出全面的建议。为了实现上述目标，进行了几次调查1)综合医院(1996年)。对3098家综合医院的院长进行了问卷调查(回收率：44%)。约15%的患者有EC。他们面临的问题是职责不清、经济问题以及没有统一的决策标准。2)医学院(1995-1996)。向所有80所医学院的执行委员会发出自填式问卷，询问现状(回收率：100%)。超过一半的人回答说，他们将独立于学术团体和部委审查问题。3)学术团体(1998年)。向137个社团的理事发送了一份自填式问卷(回收率：88%)。有28个社会有欧洲理事会。大多数社会回答说，他们不会干预，只是在他们的意见与医学院的决定相冲突时提出反对。4)卫生和福利部(1999)。对两名参与政策制定的官员进行了半结构化访谈。该部基本上对器官移植等合法化的问题进行管理和干预。最后，对于“日本的欧共体制度是独一无二的吗？”的问题，我们回答说，成员组成、地点和讨论的议题等因素似乎与其他国家的相似。与前景不同的是，分歧可能存在于其决策程序中，如寻求共识的倾向，需要进一步分析。

The growing number of ethics committees (ECs) indicates that significant changes have occurred in the decision making process in the clinical setting in Japan. The purposes of this study are to : 1) investigate the current status ; 2) make guidelines for establishing and running an EC in a general hospital setting ; 3) to explore the degree of discretion and responsibility of the EC, and 4) to make a comprehensive proposal. To achieve the above goals, several surveys were conducted.1) General hospitals (1996). A self-administered questionnaire was sent to directors of 3,098 general hospitals (recovery rate: 44%). About 15% had ECs. The problems they faced were unclearness of their responsibilities , financial issues , and no uniform decision making criteria.2) Medical schools (1995-1996). A self-administered questionnaire was sent to the EC of all 80 medical schools, asking about the current status (recovery rate: 100%). More than half of them answered that they would review issues independently from academic societies and ministries.3) Academic societies (1998). A self-administered questionnaire was sent to directors of 137 societies (recovery rate: 88%). Twenty-eight societies had ECs. Most societies answered that they would not intervene but just make objections when their opinions conflicted with medical schools' decisions.4) The Ministry of Health and Welfare (1999). Semi-structured interviews were performed with two officers who were engaged in policy making. The Ministry basically regulates and intervenes in the issues that are legalized such as organ transplantation. Other issues are handled case by case.Finally, for the question "Is the Japanese EC system unique?", we would answer that factors such as member constitution, location, and topics discussed seem to be similar to ones in other countries . Rather than the outlook, the difference might exist in its decision making procedures such as a consensus-seeking tendency, and needs further analysis.